Process Engineer

Job Title: Process Engineer

Location: Seattle-Dexter, WA 98109

Duration: 12 Months

Work Schedule: Normal Business Hours

Top 3 – 5 Must Have’s:

• Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations. Looking for a proactive and independent thinker.
• Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.
• Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.
• Exceptional interpersonal and communication skills, with a demonstrated ability to build strong relationships and a positive reputation with various teams and stakeholders.

Top Skills:

· Life Cycle Management Experience

· Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.

· Familiarity with cell therapy processes and cGMPs

· Experience assimilating large data sets in support of batch history sections for regulatory submissions.

· Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.

Position Summary:

· Cell Therapy Technical Operations (CTTO) is responsible for global product lifecycle strategy and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle.

· The Senior Engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life-cycle management of a commercial CAR-T Therapy.

· This includes establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level.

· This role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of challenges/opportunities. The candidate will help drive the validation, qualification, and comparability strategies.

Duties/Responsibilities:

· Lead the commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.

· Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.

· Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.

· Provide technical content for significant documents such as validation activities, author content for regulatory submissions.

· Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.

· Provide necessary technical analysis to support impact assessments and investigations.

· Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.

· Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.

· Present complex technical topics internally and externally.

· Share operational and process leanings with the rest of the manufacturing network

Qualifications:

· Bachelor’s or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. Familiarity with cell therapy processes and cGMPs is preferred.

· Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.

· Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

· Experience assimilating large data sets in support of batch history sections for regulatory submissions. Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.

· Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.

· Ability to assess risk and develop contingency plans for process risks

· Able to manage time and elevate relevant issues to project lead and line management.

· Detail oriented with excellent verbal and written communication skills.

· Strong interpersonal and leadership skills to work with teams in different functions and organizations